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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00533728 |
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Date of registration:
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20/09/2007 |
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Primary sponsor: |
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Public title:
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Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
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Scientific title:
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A Phase I Study to Determine the Safety and Effect of Soluble Beta-Glucan (SBG) in Combination With Rituximab and COP/CHOP in Patients With Non'Hodgkin's Lymphoma |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00533728 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Norway
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Contacts
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Name:
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Gustav Lehne, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. CD20 positive B-cell non-Hodgkin's lymphoma
2. Treatment with rituximab and CHOP or COP
3. Performance status 0 or 1 according to the WHO scale (Appendix)
4. Expected lifetime of more than 12 weeks
5. Age = 18 years
6. The patient must be able and willing to comply with the study procedures, and signed
and dated informed consent must be obtained
Exclusion Criteria:
1. Women who are pregnant or breast-feeding. For fertile women, a negative pregnancy
test must be provided during the screening test. Women of childbearing potential must
agree to use adequate contraception prior to study entry and for the duration of
study participation
2. Lymphoma involvement of central nervous system
3. Reduced bone marrow function defined by leukocyte counts < 3.0 x 109/l, neutrophil
counts < 1.5 x 109/l, thrombocyte counts < 100 x 109/l or hemoglobin < 10 g/dl
4. Reduced liver function defined by bilirubin > 1.5 x upper limit of normal (ULN) or
ASAT/ALAT = 3 x ULN
5. Reduced renal function defined by serum creatinine = 2 x ULN
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Hodgkin's Lymphoma
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Intervention(s)
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Drug: Soluble beta-glucan (SBG)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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